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Atellica CH Revised C‑Reactive Protein (RCRP)

IVDR_67_TTN_DUB-C_B_REAG_RCRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610887
Basic UDI-DI: 0405686902328VN
Reference: 11537223
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

AESKULISA® SpA Detect

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504973
Basic UDI-DI: B-04250289504973
Reference: 3190
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 10.08.2026 16:11

Manufacturer products View details

AESKULISA® MMP-3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289504898
Basic UDI-DI: B-04250289504898
Reference: 3168
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 10.08.2026 16:11

Manufacturer products View details

SmarLumi

Anti-Cyclic Citrullinated Peptide Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859608
Basic UDI-DI: B-06933289859608
Reference: WA99P0009
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Anti-Cyclic Citrullinated Peptide Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859592
Basic UDI-DI: B-06933289859592
Reference: WA99P0008
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Anti-Cyclic Citrullinated Peptide Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859585
Basic UDI-DI: B-06933289859585
Reference: WA99P0004
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Anti-Cyclic Citrullinated Peptide Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859578
Basic UDI-DI: B-06933289859578
Reference: WA99P0002
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sclero-Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158680189
Basic UDI-DI: B-04260158680189
Reference: 10121
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.08.2026 14:00

Manufacturer products View details

06973262863260

C-Reactive Protein Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262863260
Basic UDI-DI: B-06973262863260
Reference: 2012501
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

LATEX PCR TURBIDIMETRICO 1:5

LATEX PCR TURBIDIMETRICO (1:5)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155011863
Basic UDI-DI: B-18430155011863
Reference: 952530
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 07.08.2026 02:14

Manufacturer products View details

LATEX AS DIRECTO

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003271
Basic UDI-DI: B-18430155003271
Reference: 992717
EMDN: W01021105
EMDN description: ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)
First on market country: Spain
Authorised representative: -
Last updated: 07.08.2026 02:14

Manufacturer products View details

LATEX PCR TURBIDIMETRICO 1:5

LATEX PCR TURBIDIMETRICO (1:5)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155009795
Basic UDI-DI: B-08430155009795
Reference: 951530
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:31

Manufacturer products View details

LATEX FR TURBID. 1:5

LATEX FR TURBIDIMETRICO (1:5)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155009788
Basic UDI-DI: B-08430155009788
Reference: 951529
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:31

Manufacturer products View details

LATEX AS TURBIDIMETRICO 1:5

LATEX AS TURBIDIMETRICO (1:5)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155009771
Basic UDI-DI: B-08430155009771
Reference: 951528
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:31

Manufacturer products View details

Rheumatoid Factor IgA CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224902
Basic UDI-DI: B-06975424224902
Reference: CL30571E
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor IgA CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224896
Basic UDI-DI: B-06975424224896
Reference: CL20571E
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239465
Basic UDI-DI: B-06942202239465
Reference: 3012950
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x50mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239472
Basic UDI-DI: B-06942202239472
Reference: 3012869
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

RHEUMATOID FACTOR KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL, Calibration sample: 1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239694
Basic UDI-DI: B-06942202239694
Reference: 3014554
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL, Calibration sample: 2x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238093
Basic UDI-DI: B-06942202238093
Reference: 3012988
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details